MAUDE Adverse Event Report: BAUSCH + LOMB 25GA POSTERIOR PRODCEDURAL PACK WITH INTEGRATED VENTED AFI&FF; UNIT, PHACOFRAGMENTATION

Model Number	BL5425V
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation completed.One 25ga vitrectomy cutter was returned in a plastic bio-hazard bag along with a bl5425v pack label from lot w0290.The expiration date on the label is 2019-03-10.Visual inspection found the tip protector was not returned.The needle was not bent.The port window was in the opened position.There was fluid in the tubing.The back cap was aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.The cutter had good clean cuts throughout the various cut rates and it aspirated as intended.
Event or Problem Description
The user facility reported the cutter was not working.Patient contact, but no patient injury.Additional information: the cutter intermittently stopped cutting, but continued to aspirate.

• Brand Name: 25GA POSTERIOR PRODCEDURAL PACK WITH INTEGRATED VENTED AFI&FF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7277912
• Report Number: 0001920664-2018-00015
• Device Sequence Number: 19408483
• Product Code: HQC
• UDI-Device Identifier: 00757770058600
• UDI-Public: (01)00757770058600(17)190310
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/10/2019
• Device Model Number: BL5425V
• Device Catalogue Number: BL5425V
• Device Lot Number: W0290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1